The 2014 Global Food Safety Conference (GFSC) in Anaheim, CA, featured a session sponsored by SGS United Kingdom Ltd. on allergen management as an integral part of a safe food supply chain, which was followed by the dissemination of a white paper summarizing the results of an industrywide survey on current allergen management practices across the food supply chain.[1] The findings prompted a number of questions that Food Safety Magazine (FSM) presented to a distinguished panel of industry experts aimed at identifying the key elements of an effective allergen control plan as well as building awareness, and sharing and promoting best practices to help direct the food supply chain to consistently and effectively implement best practices for allergen management (see “Allergen Management and the VITAL® Tool”) .
The panel included Joseph Scimeca, Ph.D., vice president, global regulatory and scientific affairs, Cargill; R. Craig Wilson, vice president of QA, food & product safety, merchandise services at Costco Wholesale; Steven M. Gendel, food allergen coordinator, U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN); Stefano Luccioli, M.D., scientific adviser and reviewer, CFSAN’s Office of Food Additive Safety; Michael A. Pascucilla, M.P.H., REHS, CEO/director of health, East Shore District Health Department, Branford, CT; Dan Skrypec, Ph.D., chief toxicologist, food safety, Mondelëz International; David Crownover, product manager, ServSafe, National Restaurant Association; and Joseph Baumert, Ph.D., assistant professor in the department of food science & technology and codirector of the Food Allergy Research & Resource Program at the University of Nebraska, Lincoln.
FSM: What do you feel is the top reason for inconsistency in allergen risk interpretation and management? How would you propose addressing this knowledge gap in the food industry?
Scimeca: My sense is that the food industry generally understands and appreciates the potential health risk associated with food allergens, but that the nature of the hazard, inherently a food ingredient, makes its management and control within a dynamic food manufacturing environment very challenging. Unlike other food hazards, where detection plays a significant role in the control of the hazard, with food allergens, the chief reason for food allergen control failure is not primarily one of hazard detectability and control, but one of faultless compliance with control measures that ensure alignment between the formula, product and package label. Hence, the greatest challenge of allergen risk management is one of operational excellence within a rapidly and frequently changing manufacturing environment.
To address this knowledge gap requires a greater recognition by the industry of the principle cause of allergen control failures. Unlike many chemical hazard control failures in food manufacturing, the true risk from allergen control failure is not due to challenges in detectability and lack of operational control through separation, albeit these are not without some importance. Rather, it lies with errors involving management systems. The vast majority of allergen risk to the consumer, and consequently the greatest cause of recalls, stems from the relatively minimal use of automated management systems for allergen control by the industry. The effective use of automated systems that flawlessly verify allergen ingredient declaration through ensuring alignment between formula, the product as manufactured and the package label will provide the greatest reduction of allergen control failures. By way of example, the use of an automated in-line label scanner will ensure an unfailing match between the product and the package label. To the extent that the broad food industry can be educated on the true cause of allergen failures, and taught about the effectiveness of automated systems to prevent human errors, the knowledge gap can be addressed, which in turn will lead to enhanced measures taken by the industry to reduce food allergen risk.
Wilson: This is a twofold issue:
1. Clear understanding of what an allergen is and
2. Appropriate item labeling for consumer awareness.
Gendel: The risk posed by unlabeled allergens for food-allergic consumers has received increased attention and is much better understood today than it was before the implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). At the same time, our understanding of the complexity of the problem has increased. In the future, it will be important to reduce the gap between academic and clinical research and the real-world problems faced by manufacturers.
Luccioli: I find there is a lack of consistent, clear understanding by the food industry, consumers and the medical community of the hazard/risk posed by small amounts of allergens in food. There must be better consideration of what ppm levels or other analytical results depicting the presence of allergens signify in relation to total exposure and potential for reactions to the product. Also, there is inconsistency among product labels in communicating risks posed by allergen exposures from different cross-contact scenarios.
It is my observation that some companies employ a zero-allergen-tolerance policy and thus tend to place an allergen label or warning on any product, even when the risk is negligible or possibly nonexistent. This may reduce risk but may not be beneficial to consumers, as it limits the number of potentially nutritious products available to them. Other companies use risk management strategies that may underestimate the hazard. These companies argue that they are doing a good job by keeping allergens at less than 1% in the finished product. Less than 1% could still signify hundreds of ppm of allergen in the finished product. This could easily lead to exposures to allergens in the mg protein range per serving—doses shown to cause reactions in allergic consumers and to be associated with severe reactions.
I find there is also a lack of consistency in use/intent of precautionary statements and how these statements are applied to specific cross-contact scenarios. The food industry maintains a position that a precautionary statement should be viewed as a warning to an allergic person not to consume the product. However, by allowing a multitude of different precautionary statements on food products that convey different risk information to consumers, the food industry appears to be endorsing a policy aiming to provide consumers a choice about which products may be consumed or not. This policy sends a mixed message. Also, the food industry does not consistently define what these statements represent and for which products or cross-contact risk scenarios they should be used. Thus, the same type of statement may be used for both high- and low-risk products. Since consumers may look for and rely on certain types of precautionary statements as denoting products that are safe to eat, should they choose to consume the high-risk product, this increases the chances for adverse outcomes.
Information on allergen “threshold” doses in relation to health-risk endpoints (i.e., percentage of individuals in the allergic population likely to react to and/or have severe allergic reactions to a given allergen dose exposure) will help fill knowledge gaps by giving risk managers a clearer understanding of adverse health consequences to the consumer posed by varying allergen residue levels in products. This information, in combination with actual data on allergen levels in products from various ingredients or cross-contact scenarios, would also help identify and stratify products based on low vs. high risk for allergic reactions—knowledge that can be used to better inform consumers and the medical community about true allergenic hazards posed by certain products. Thus, limiting the number of precautionary label statements to only a few statements that can convey specific product risk would lead to more effective communication about allergic reaction risks to products and better acceptance of/compliance with precautionary statements by allergic consumers.
Pascucilla: Food allergies are misunderstood, and in general, they are not considered a significant problem by the general public, as there is a lack of understanding and knowledge about this worldwide food supply safety problem. However, foodservice stakeholders at all levels understand (or are starting to realize) that food allergies must be addressed, as both consumers and food industry regulators have demanded change. Food allergies are a food safety concern that impacts people’s quality of life. In fact, food allergies are not just an inconvenience, but have been proven to be harmful and at times deadly. People also need to understand the difference between an allergy, intolerance and preference.
Food allergies are a public health concern that must be addressed from the farm to table. Like any other public health matter, prevention starts with education. All foodservice industries must educate their employees on food allergies, as this issue is a food safety matter. Food allergy reactions, like food poisonings, are preventable, and management must make this a priority and set food allergy educational expectations and lead the way for their businesses/organizations.
There is also a consumer responsibility. The consumer must be honest with the food establishments as far as what their allergies are and how severe [they are], and they need to ask the right questions to keep themselves safe. In the same respect, the food establishments must be honest with the consumer and have the knowledge to properly respond to food-allergic individuals. Training staff to have the understanding of allergens and ingredients is essential and a key step toward prevention and awareness. In restaurants, this food allergy safety awareness is everyone’s duty and needs to be seamless from servers to chefs, as well as the consumer.
Skrypec: Typically, food safety hazards are evaluated and managed through risk assessment practices with the objective of protecting the public. In the United States, FALCPA requires labeling of the presence of so-called major food allergens. By default, the law requires use of a “zero threshold,” meaning that any detectable level of a major food allergen triggers the labeling requirement. Consequently, industry relies on analytical results of “none detected” to provide assurance of allergen management. However, there are sound scientific data to show that the safe level of allergens is higher than zero and that there are “thresholds” below which an allergen does not constitute a food safety hazard. Over time, we expect that FDA’s regulatory policy will account for these thresholds in order to bridge the gaps in allergen risk interpretation and management within industry. Importantly, education and training regarding the appropriate consideration and application of these thresholds within the production environment, including sanitation practices, will be necessary for meaningful labeling changes, which could provide greater product choice for the allergic consumer.
Crownover: For the foodservice industry, general awareness and understanding the importance of food allergens continue to be the biggest issue. In 2012, the National Restaurant Association [NRA] commissioned a survey of restaurants and their awareness of food allergies and their use of training in their restaurants: 87% of the respondents stated that food allergy training is extremely important, yet 43% do not do any formal food allergy training. There was also 1% that claimed that they do not serve any “allergic” food. So while there is recognition of importance, there is still a fairly large gap in actually identifying whether they can and will accommodate individuals with food allergies or that they even have food allergens in their operations.
Based on the results of the 2012 survey, NRA identified the need to offer a food allergen awareness course to its customers. It also partnered with Food Allergy Research and Education, the leading voice of the allergic consumer, to demonstrate the importance of this issue to the foodservice industry. This course is specifically designed for the foodservice industry and addresses general food allergy information, front-of-the-house and back-of-the-house issues. NRA also actively speaks at various conferences across the country to help raise the general awareness of food allergens in restaurants and ultimately demystify the concept of food allergy management in foodservice.
Baumert: My observation is that much of the food industry understands the importance of food allergens and the critical need to carefully manage allergens to ensure the safety of allergic consumers. With that said, there are certainly differences with which individual companies assess and interpret allergen risks, and these differences are often apparent with the various precautionary statements that are used on packaged food labels. Declaration of ingredients derived from the eight priority allergenic foods is required by food manufacturers with the passage of FALCPA; however, the law does not dictate when labeling should be used in the event of potential cross-contact situations. FALCPA did, however, essentially establish a zero threshold for labeling as well as for cross-contact potential. It is operationally impossible to guarantee the complete removal of every molecule of allergenic residue (a true zero-threshold scenario) in a facility that produces numerous products with varying allergen profiles on shared equipment. As a result of this uncertainty, precautionary or advisory statements have increased in use and complexity.
I do not think that this is a knowledge gap that contributes to the inconsistency in allergen risk interpretation and management, but rather uncertainty surrounding congressional labeling laws and interpretation and enforcement of these laws. The food industry as a whole needs a single standard by which they can systematically assess allergen risks. The Voluntary Incidental Trace Allergen Labeling [VITAL] program developed by the Allergen Bureau of Australia and New Zealand could prove to be this single standardized approach; however, the program will unfortunately not be widely adopted by food companies in the U.S. unless it receives some acknowledgment by regulators as an acceptable approach for allergen risk assessment and labeling decision making. To do so, however, would require regulators to acknowledge that a population “threshold” or reference dose does exist, something that the agencies have been reluctant to do at this point in time.
FSM: What do you believe is the weakest link in the food supply chain with regard to allergen management, and how do you propose improvements should be made?
Scimeca: The weakest link in the consumer packaged food supply chain is the need for the consistently accurate flow of allergen-related information about the food from one supplier in the supply chain to the next. To the extent that the final manufacturer of a consumer packaged food product has received full disclosure of all food allergens present in the ingredients used in the formulated product, and has effective systems and manufacturing control measures to prevent cross-contact and mislabeling, then the manufacturer should be able to accurately disclose the presence of allergens in the finished product. Too often, a manufacturer is focused on their operational control measures and fails to adequately devote the resources necessary to ensure that their suppliers have fully disclosed allergens in their products and maintained operational allergen control. In addition, customers need to set clear expectations from their suppliers about the need to adequately convey any changes in their products that might impact the presence of allergens.
Wilson: Certainly allergen identification and standards along the complete supply chain are an ongoing problem. It may well be time for stronger regulatory intervention; catching a problem after the fact and doing recalls seems too late.
Gendel: An analysis of food allergen recalls for FDA-regulated food products suggests that one of the most significant supply chain problems lies in the communication links between suppliers and manufacturers, particularly when there are changes in ingredient formulations. This may be a reflection both of the variety of ways that suppliers provide information (e.g., through certificates and analysis, ingredient specifications, labels, information on invoices, etc.) and of the separation between development and production functions at manufacturers.
Allergen Management and the VITAL® Tool
Globalization of the food industry has created a complex food supply chain, bringing with it the risks associated with cross-contamination (or cross-contact) of allergens prior to supply, in process and during storage and distribution. Contamination of foods with allergens and/or mislabeled product is now one of the most common causes for food recalls. Other common causes include:
• Inadequate assessment, identification and management of direct and cross-contact allergen risks in storage and processing environments
• Poor assessment of ingredient specifications and presence of allergen in trace amounts across a range of ingredients
• Lack of control or awareness of labeling ingredient declarations and appropriate risk-based, cross-contamination precautionary statements (i.e., may be present)
• Poor management of label or packaging change controls on production lines at product changeover
Management and verification of allergens in processing are challenged by the allergen thresholds or “acceptable level.” Currently, there are no thresholds (except Japan: 10 ppm); as a result, industry works on an “operationally zero” impossible threshold.
To further complicate the issue, clinical threshold studies have previously presented data in an inconsistent format, such as mg or ppm of protein vs. units of whole food. Threshold levels vary based on dosage, with data gaps noted particularly for tree nuts (almonds, walnuts). Considerations for likelihood of a reaction in allergic consumers are based on prevalence, threshold and consumption of a specific product. There is also considerable variation globally with regard to regulatory requirements for allergen labeling; for example, sesame is not required to be labeled as an allergen in the U.S. but is required in Canada; the reverse situation is noted for Crustacea.
In 2007, the Australian Allergen Bureau released the Voluntary Incidental Trace Allergen Labeling (VITAL®) tool, revised in 2012, based on scientifically determined action levels for key allergens. VITAL provides a risk-based assessment process inclusive of allergen assessments for ingredients and through to the manufacturing, production and packing processes. VITAL not only allows food producers to assess the impact of allergen cross-contact but also specifies the precautionary allergen statement according to the level of allergen cross-contact identified. The aim is to provide consistency in allergen declarations to enable allergic consumers to make accurate, informed decisions. The VITAL tool and training in its effective application are a mandatory requirement for suppliers to some Australian retailers.
–Margaret Balfour, managing director,
Integrity Compliance Solutions (ICS), and Leanne Singleton, executive manager, program development, ICS